The process of lining up the next wave of vaccines – Vax 2.0 – is likely already underway behind closed doors at major science institutes, throughout top research think-tanks, and at the home bases of the major vaccine-oriented pharma players.
Vax 2.0 is no longer a theory. It’s already in the works. The Covid-19 variants are simply piling up too quickly, and too much of the world’s population remains unvaccinated. The world continues to be a petri dish of Darwinian trial and error for breaking the efficacy barrier for our current field of vaccines.
It’s not a matter of “if” but “when”.
According to leading experts, that “when” timeframe is now thought to be either later this year or early in 2022. And, yes, unfortunately, that means you will have to go and get another shot or two. But get used to it. After Vax 2.0, we will get to Vax 3.0, and so on.
This is now an endemic part of human life. You will get used to it. It’s not such a big price to pay. There are so many things you already have to do to stay healthy and safe. And you do most of them without complaint or bitterness. How about going to the grocery store – all that annoying “eating” you have to do to stay alive. The gas station. The pharmacy. The dentist. Water. Sleep. The list goes on and on. Stuff you do to not have catastrophic system failure as a human organism.
There’s just going to be one more of those – Covid shots every 6-12 months.
If there’s any chance of avoiding a lifetime of that fate, we would need to find a better way of simultaneously vaccinating 50-75% of the world within a 6-month timeframe. That might squeeze this bug more or less out of commission. But our current solutions don’t seem to be able to do it. We haven’t even gotten to 20% of the world in the past 6 months. The cost and timeframe of production are both too high.
With that in mind, we survey some interesting players in the space, including Pfizer Inc (NYSE: PFE), Novavax Inc (NASDAQ: NVAX), Dyadic International Inc (NASDAQ: DYAI), and Moderna Inc (NASDAQ: MRNA).
Pfizer Inc. (NYSE: PFE) trumpets itself as discovers, develops, manufactures, and sells healthcare products worldwide. It is also now probably the frontrunner in terms of the Vax 1.0 Covid vaccine landscape given the efficacy numbers attached to its vaccine program thus far.
It operates in two segments, Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). The IH segment focuses on the development and commercialization of medicines and vaccines, and consumer healthcare products in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases, as well as consumer healthcare, such as over-the-counter brands comprising dietary supplements, pain management, gastrointestinal, and respiratory and personal care.
Pfizer Inc. (NYSE: PFE) most recently announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA).
According to the release, the primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines.
Even with that news, the action hasn’t really heated up in the stock, with shares moving net sideways over the past week.
Pfizer Inc. (NYSE: PFE) managed to rope in revenues totaling $14.6B in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top-line growth of 21.2%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($13.7B against $26.7B, respectively).
Novavax Inc (NASDAQ: NVAX) bills itself as a clinical-stage biotechnology company that focuses on the discovery, development, and commercialization of recombinant nanoparticle vaccines and adjuvants. Its lead adjuvant is Matrix-M that is used to enable a vaccine to enhance the amplitude of the immune response and qualitatively change it, enhance its specificity to provide protection against related microorganisms, as well as allows immunization with much lower doses of antigen.
The company develops respiratory syncytial (RSV) virus fusion protein nanoparticle vaccine candidate for infants via maternal immunization in Phase III clinical trial; older adults in Phase II clinical trial; and children six months to five years of age in Phase I clinical trial.
Novavax Inc (NASDAQ: NVAX) most recently announced the signing of a non-binding memorandum of understanding (MoU) with the Ministry of Health and Welfare of Korea (MOHW) and SK bioscience, Co. Limited, a vaccine business subsidiary of SK Group, to explore further cooperation in the development and manufacturing of vaccines, including NVX-CoV2373, Novavax’ recombinant protein COVID-19 vaccine candidate.
“Our strategic partnership with SK bioscience demonstrates Novavax’ commitment to global access to our vaccine, including for the people of South Korea and around the world,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax. “We thank the Ministry of Health and Welfare for its support as we work together toward the shared goal of promoting and enhancing global public health.”
The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 2% in that timeframe.
Novavax Inc (NASDAQ: NVAX) generated sales of $447.2M, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of 59.9% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($2B against $1.2B).
Dyadic International Inc (NASDAQ: DYAI) continues to take strong steps as a dark horse candidate to reshape the global vaccine landscape. The company posted results and an in-depth update late last week, and it is now heading toward a bit of road show for its somewhat revolutionary new angle on the problem identified in the introduction section above.
For a little background, DYAI has a new approach that could become a better way to deal with new variants and even possibly better able to drive cheap and efficient production capable of vaccinating the world. The jewel in this new model is its proprietary process involving the C1 microorganism, which enables the development and large-scale manufacture of low-cost proteins and has the potential to be further developed into a safe and efficient expression system that may help speed up the development of biologic vaccines and drugs at commercial scales while lowering production costs and improving performance at the same time.
Dyadic International Inc (NASDAQ: DYAI) most recently announced that it will participate in the Jefferies Virtual Healthcare Conference Tuesday, June 1, 2021, at 9:00 a.m. ET, and the BIO International Convention Digital Conference June 10-11 & 14-18, 2021.
According to the release, at the Jefferies event, Mark Emalfarb, President and CEO of Dyadic, will provide a corporate overview and update on the Company’s progress in advancing its C1-Cell Protein Production Platform for use in reducing the costs of manufacturing proteins for animal and human health applications, most notably its COVID-19 vaccine candidate, DYAI-100, toward a first-in-human Phase 1 clinical trial later this year. Management will be available throughout the day on June 1 for virtual one-on-one meetings.
At the BIO Intl event, the company’s presentation, A TRANSFORMATIONAL PLATFORM THAT TRANSCENDS THE LIMITS OF LEGACY PROTEIN PRODUCTION TECHNOLOGIES – Dyadic’s Thermophilic Filamentous Fungus (C1 platform) Recombinant Production of Glycoprotein Antigen Vaccines, Antibodies & Other Therapeutic Protein Products, will be available on-demand and management will be available for virtual one-on-one meetings. https://www.bio.org/events/bio-digital
The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 8% in that timeframe. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -18%.
Dyadic International Inc (NASDAQ: DYAI) pulled in sales of $461K in its last reported quarterly financials, representing top-line growth of 46%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($27.2M against $2.6M). That said, if the company is successful in its larger strategy, this one could jump from small-time to global leadership, suggesting that its current financial performance figures don’t really scratch the surface of the speculative opportunity in play for DYAI.
Moderna Inc (NASDAQ: MRNA) promulgates itself as a clinical-stage biotechnology company that develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and autoimmune and cardiovascular diseases.
As of February 14, 2020, the company had 12 programs in clinical trials and a total of 24 development candidates in six modalities comprising prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted and cell surface therapeutics, and systemic intracellular therapeutics.
Moderna Inc (NASDAQ: MRNA) most recently announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary CDC case definition of COVID-19, which tested for milder disease. This study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years in the U.S. The Company plans to submit these data to regulators globally in early June.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 6% in that timeframe.
Moderna Inc (NASDAQ: MRNA) pulled in sales of $1.9B in its last reported quarterly financials, representing top-line growth of 22989.8%. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($7.7B against $8.4B, respectively).
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